AccessGUDID - DEVICE: Tendril™ (05414734005715)

GUDID

Device Identifier (DI) Information

Brand Name: Tendril™
Version or Model: SDX
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1688T-100
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734005715
Issuing Agency: GS1
Commercial Distribution End Date: February 13, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: Pacing Lead

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35223	Endocardial/interventricular septal pacing lead	An implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DTB	permanent pacemaker Electrode

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P960013	013

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -5 and 50 Degrees Celsius
Handling Environment Temperature: between -5 and 50 Degrees Celsius
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 100 Centimeter

Device Record Status

Public Device Record Key: fc305c2b-71f5-45ef-aace-11b8c49caa98
Public Version Date: March 20, 2024
Public Version Number: 5
DI Record Publish Date: April 10, 2017